Change in nasal congestion index after treatment in patients

with chronic rhinosinusitis with nasal polyposis

Serap Sahin-Onder, M.D.,1 Asli Sahin-Yilmaz, M.D.,2 Cagatay Oysu, M.D.,2 Ildem Deveci, M.D.,2
Samil Sahin, M.D.,2 and Betul Aktas, M.D.2

ABSTRACT
Background: The management of chronic rhinosinusitis with nasal polyposis (CRSwNP) involves both surgical and medical
approaches, and remains a controversial subject.
Objective: The objective of this prospective, randomized, controlled trial was to compare the medical and surgical treatments
of CRSwNP in terms of their effect on the nasal congestion index (NCI).
Methods: Forty-eight patients with CRSwNP were randomized either to medical or surgical therapy. Pretreatment and 3-
and 6-month posttreatment assessments of the visual analog scale score, the 20-Item Sino-Nasal Outcome Test, saccharine
clearance time, nasal endoscopy, and NCI measurement with acoustic rhinometry were performed. Forty-one subjects were
included in the analysis.
Results: Both the medical and surgical interventions for CRSwNP resulted in significant improvement in the visual analog
scale score, 20-Item Sino-Nasal Outcome Test, saccharine clearance time, and nasal endoscopic examination scores. There was
no difference between the two groups in terms of the percentage change from baseline for any of the parameters at the 6-month
posttreatment assessment. NCI showed no significant difference from baseline. Similarly, no significant difference was found
between the medical and surgical groups in terms of their effect on the NCI (p 0.05).
Conclusion: Because NCI does not correlate with standard subjective measures in outcomes for this group of patients, it
cannot be used as an outcome measurement of treatment of subjects with CRSwNP. Results of this prospective randomized
study did not find any additional benefit of surgical therapy over medical therapy in subjects with CRSwNP.
(Allergy Rhinol 7:e193e199, 2016; doi: 10.2500/ar.2016.7.0177)

N asal polyposis is a benign inflammatory disease of

the nasal cavity and paranasal sinuses. This con-
dition is considered a subgroup of chronic rhinosinus-
itis. The symptoms include nasal obstruction, poor si-
nus drainage, loss of smell, runny nose, and nasal
congestion. Chronic rhinosinusitis with nasal polyposis
(CRSwNP) affects 4% of the population.1 A diagnosis of
CRSwNP is based on a history, anterior rhinoscopy, en-
doscopic examination, radiology, and histopathology.
The management of CRSwP involves both surgical and
medical approaches, and remains a controversial subject.2
The aims of both modalities are to relieve nasal ob-
struction, restore olfaction, improve sinus drainage,
and treat any accompanying rhinitic symptoms.3 Med-
ical therapy includes antimicrobials, nasal and oral corti-
costeroids, decongestants, antihistamines, mast cell stabi-
From the 1Otolaryngology Clinic, Amasya Suluova Government Hospital, Amasya,
Turkey, and 2Otolaryngology Clinic, Umraniye Education and Research Hospital,
Istanbul, Turkey
No external funding sources reported
The authors have no conflicts of interest to declare pertaining to this article
Oral presentation at The Turkish Otolaryngology Society annual meeting, Antalya,
Turkey, October 28 31, 2015
Address correspondence to Asli Sahin-Yilmaz, M.D., Otolaryngology Clinic, Um-
raniye Education and Research Hospital, Istanbul, Turkey
E-mail address: aslisahin@hotmail.com
Copyright 2016, OceanSide Publications, Inc., U.S.A.
lizers, antileukotrienes, nasal douching, immunotherapy,
and reduction of environmental factors. Corticosteroids
are the only medical therapy to have a proven effect on
the symptoms and signs of CRSwP, and can be used
topically or systemically.4 The initial surgical manage-
ment of CRSwP is endoscopic sinus surgery.
A recent Cochrane database review on the surgical
versus medical interventions for CRSwP concluded
that the evidence that related the effectiveness of dif-
ferent types of surgery versus medical treatment is of
very low quality. It is unclear whether one treatment is
better than the other in terms of patient-reported
symptom scores and quality of life measurements.2 A
measurement for quantification of mucosal congestion
has been defined by several investigators.57 The nasal
congestion index (NCI), as designated by Kjeargaad et
al.7 in 2009, indirectly assesses the amount of reversible
mucosal congestion in the anterior and middle parts of
the nasal cavities. NCI has been proven to be useful for
evaluating patients with symptoms of nasal obstruc-
tion. Subjects with severe nasal obstruction have been
shown to have significantly higher NCI than subjects
with mild or moderate symptoms.6,7 We believe that
the NCI in subjects with CRSwNP may influence their
postoperative quality of life. Therefore, we conducted a
randomized prospective controlled study that evalu-
ated the subjective and objective outcomes for the

Allergy & Rhinology e193


surgical versus medical treatment of CRSwNP and
added the NCI as an objective outcome measure-
ment. As far as we know, our study was the first
randomized controlled, prospective study that used
this parameter as an outcome measurement in sub-
jects with CRSwNP.
METHODS
Patients were recruited from the Otorhinolaryngol-
ogy Clinics, Umraniye Research and Education Hospi-
tal. The protocol of the study and the methods of
consent had been approved by Umraniye Research and
Education Hospital Ethics Committee. The process of
recruitment took place over 1 year. The flow chart and
design of the study were planned similar to the excep-
tional study by Ragab et al.8 and is shown in Fig. 1. The
study was discussed with 96 consecutive patients with a
primary diagnosis of CRSwNP. Forty-eight of the pa-
tients were excluded (20 of them did not meet the study
criteria, 28 of them responded to initial medical treat-
ment). Allocation was concealed from both the study
participants and investigators before randomization. For-
e194
Figure 1. The study design.
ty-eight patients were randomized for inclusion in the
study by using computer-generated random numbers.
The diagnosis of CRSwNP was primarily based on
the criteria described by the European Position Pa-
per on Rhinosinusitis and Nasal Polyps,9 which de-
fines these conditions clinically as inflammation of
the nose and paranasal sinuses, associated with two
or more of the following symptoms for a duration of
12 weeks:
blockage/congestion; discharge (anterior or postna-
sal drip); facial pain/pressure; reduction of smell;
and
either endoscopic evidence of polyps; mucopurulent
discharge from the middle meatus or edema/mucosal
obstruction primarily in the middle meatus; and/or
mucosal changes within the osteomeatal complex or
sinuses on computed tomography (CT) imaging.
The exclusion criteria were children 18 years of
age, pregnancy, psychological problems, systemic dis-
eases that affect the nose, acute upper or lower respi-
Winter 2016, Vol. 7, No. 4
ratory tract infections within 2 weeks, use of systemic
corticosteroids within 4 weeks before the inclusion
visit, and other medical or surgical treatments that may
influence the study.
Subjective Assessment
Subjective assessment of patients was made by using a
visual analog scale (VAS) of 0 to 10 cm. Nasal blockage or
congestion, nasal discharge, olfactory disturbance, facial
pain or pressure, headache, and overall discomfort were
used as the scoring criteria. A total score was calculated.
The 20-Item Sino-Nasal Outcome Test (SNOT-20) was
also used in this study. Assessment included 20 symp-
toms and social and emotional consequences.
Examination of the Nose. Nasal endoscopy was per-
formed in all the subjects. The scoring system by Mackay
was used, which evaluated the following: nasal polyps
size (0, none; 1, limited to the middle meatus; 2, filling the
nasal cavity), the presence of pus (0, no; 1, thin purulent;
2, mucoid), edema, crusting, and scar.10 When present
during the endoscopic examination, edema, crusting, and
scar were scored as 1 point for each.
Objective Measurements
Acoustic Rhinometry. Measurements were taken with
the use of acoustic rhinometry (Interacoustics, Assens,
Denmark). During the measurements, the subjects sat
erect in the chair and kept the head perpendicular to
the horizontal plane. They were instructed to hold their
breath during the measurement. The test was repeated
three times, and estimates of the minimum cross-sec-
tional area and volume of the nasal cavity were calcu-
lated from the mean of the three sets of five measure-
ments. Measurements from both nostrils were
averaged to get an overall mean value to represent
both nasal cavities and to account for variations be-
tween nostrils due to the nasal cycle.7 The measure-
ments were repeated 10 minutes after application of a
topical nasal decongestant (0.1% xylometazoline hy-
drochloride nasal spray) to both nostrils. The parame-
ters used for the calculation of NCI included the total
minimal cross-sectional area (MCA3) and the volume
of the nasal cavity between 0 and 5 cm from the tip of
the nosepiece (VOL3). The NCI was calculated for the
total MCA3 (NCI-MCA3) and the total VOL3 (NCI-
VOL3) by using the following formula by Kjaergaard7:
NCI (postdecongestant value
baseline predecongestant value)/
(baseline predecongestant value 100)
SCT. One saccharine tablet was placed 1 cm behind
the anterior end of the inferior turbinate of the subjects
Allergy & Rhinology
nasal cavity while the subjects were in a sitting posi-
tion. The subjects were asked to breathe through the
nose normally but not to sniff, sneeze, eat, or drink.
When the subject perceived a sweet taste, then the SCT
was recorded in minutes and seconds by using chro-
nometer.
Medical Treatment
Initial Medical Treatment. The initial medical treat-
ment included a 6-week regimen of a nasal douche and
fluticasone furoate (FF) intranasal spray. The nasal
douche powder was a preservative- and iodine-free,
pH balanced, sodium chloride, sodium bicarbonate
mixture. The subjects were instructed to use the
douche twice daily 15 minutes before taking FF, deliv-
ered as two puffs into each nostril twice daily. The
subjects who remained symptomatic after this treat-
ment were randomized into the study.
Medical Treatment for the Medically Randomized Group.
All the patients received a 12-week course of clarithro-
mycin, nasal douche, intranasal fluticasone propionate
nasal drops, and oral steroids. Clarithromycin was pre-
scribed orally as 500 mg twice daily for 2 weeks, fol-
lowed by 250 mg twice daily for 10 weeks. Nasal
douche was prepared and used as described elsewhere
in the text. All the patients received a 12-week course
of twice daily use of 400 g of fluticasone propionate
nasal drops into each nostril, and were prescribed a
9-day course of oral prednisolone tablets, 30 mg for 3
days, 20 mg for 3 days, and 10 mg for 3 days.
Surgical Treatment
In all the patients, endoscopic sinus surgery with the
patient under general anesthesia was performed by
two surgeons (S.O., A.S.Y.). The extent of the proce-
dure was tailored to the extent of sinus disease as
documented by nasal endoscopy and computed to-
mography findings. A microdebrider was used in all
the cases. At the end of the procedure, a portion of a
Merocel (Jacksonville, MN) sinus pack was inserted
into the ethmoidal cavity on each side and was re-
moved on the following day. Operative findings and
complications were documented for all the subjects.
Medical Treatment after Surgery. After endoscopic si-
nus surgery, all the patients were prescribed a 2-week
course of twice daily use of 500 mg of clarithromycin,
FF, and nasal douche, which was followed by a
3-month course of twice daily use of 100 g (2 sprays)
of FF intranasal spray into each nostril and nasal
douche. After that, the medical treatment was tailored
to the patients manifestations, which usually included
topical FF. None of the subjects received oral steroids
after surgery.
e195
Table 1 A comparison of the medical and surgical groups in terms of baseline parameters
Baseline Parameters Surgical Group Medical Group p
Age, mean SD, y 40.8 11.9 45.19 15.1 NS
Men/women, % 65/35 66/34 NS
VAS score, mean SD 30.9 10.33 28.19 8.21 NS
SNOT-20 score, mean SD 37.9 23.77 35.86 17.59 NS
Examination of the nose, mean SD 3.25 1.37 3.95 1.6 NS
NCI-MCA3, mean SD 0.38 0.35 0.21 0.23 NS
NCI-VOL3, mean SD 0.15 0.15 0.21 0.23 NS
SCT, mean SD 13.5 9 14.4 8.9 NS
Other medical conditions, mean SD none none NS
SD Standard deviation; NS nonsignificant; VAS visual analog scale; SNOT-20 20-Item Sino-Nasal Outcome Test;
NCI-MCA3 nasal congestion index for minimal total cross-sectional area; NCI-VOL3 nasal congestion index for total
volume; SCT saccharine clearance time.

Figure 2. The change in the visual

analog scale score (VAS) of the medical
and surgical groups.

Statistical Methods RESULTS

The analysis was performed by using SPSS for Win-
dows (IBM SPSS, Istanbul, Turkey). Parametric tests,
such as the paired t-test and analysis of variance, were
used for the parameters that showed a normal distri-
bution. For the data that did not follow a normal dis-
tribution, the Mann-Whitney U test was used. A p
value of 0.05 was considered significant.
The final analysis included 41 patients in total (27
men and 14 women), with a mean age of 43
years.
Baseline Data
There was no statistically significant difference be-
tween the medical and surgical groups in the baseline

e196 Winter 2016, Vol. 7, No. 4

Figure 3. Baseline, and 3- and
6-month measurements of the nasal
congestion index for the total nasal
cavity volume (NCI-VOL3) of both
groups.
data of any of the following parameters: demographic
characteristics, VAS, SNOT-20, saccharine clearance
time (SCT), NCI-MCA3, NCI-VOL3, and the endo-
scopic score (Table 1).
Subjective Assessment
VAS. In the 3- and 6-month follow-up data, we saw
that all the groups experienced a significant im-
provement in the total VAS scores (p 0.01) (Fig. 2).
There was no statistical difference between the med-
ical and surgical groups (p 0.05). The difference
between the two groups for the 3- and 6-month
percentage change in VAS from baseline was statis-
tically insignificant (p 0.05). Changes and signifi-
cance tests of VAS in the medical and surgical
groups are illustrated in Table 1.
SNOT-20. In the 3- and 6-month follow-up settings,
the total SNOT-20 scores showed a significant im-
provement in all the groups (p 0.01), whereas there
was no statistical difference between the medical and
surgical groups (p 0.05). The comparison of the
percentage change in SNOT-20 scores from baseline
for the 3- and 6-month for the two groups revealed
no statistical significance (p 0.05).
Examination of the Nose. In the 3- and 6-month set-
tings, endoscopic scores increased significantly
when compared with the baseline levels (p 0.05).
For the 3-month examination, the surgical group had
Allergy & Rhinology
a significantly higher change in the endoscopic
scores (p 0.05). No statistical evidence for signifi-
cant difference was detected among the surgical and
medical groups for the 6-month scores (p 0.05).The
differences between the 3- and 6-month scores were
statistically insignificant as well (p 0.05).
Objective Measurements
SCT. In the 3- and 6-month follow-up settings, SCT
improved significantly (p 0.05), whereas there was no
statistical evidence for the percentage change from base-
line between the medical and surgical groups (p 0.05).
Acoustic Rhinometry
NCI-MCA3. There was no statistically significant dif-
ference between the baseline measurements of the two
groups for NCI-MCA3. The 3- and 6-month NCI-
MCA3 of the medical and surgical groups did not
show any significant changes from the baseline mea-
surements. The difference between the surgical and
medical groups in terms of the percentage change from
baseline for MCA3 was not significant in terms of NCI
on postoperative months 3 and 6 (p 0.05).
NCI-VOL3. There was no statistically significant dif-
ference between the baseline measurements of the two
groups for NCI-VOL3. The 3- and 6-month NCI-VOL3
of the medical and surgical groups did not show any
significant changes from the baseline measurements
(Fig. 3). The difference between the surgical and med-
ical groups in terms of the percentage change from
e197
baseline for VOL3 was not significant in terms of NCI
on postoperative months 3 and 6 (p 0.05).
Adverse Events. One patient in the medical group
developed arrhythmia. He had to stop medical treat-
ment and was excluded from the study.
DISCUSSION
In our study, the medical treatment of CRSwNP
(which consists of 12 weeks of clarithromycin, nasal
douche, prednisolone, fluticasone propionate) resulted
in a significant improvement in total VAS, SNOT-20,
and endoscopic examination scores, and in the muco-
ciliary clearance rate. Similarly, the surgical treatment
of CRSwNP with endoscopic sinus surgery had a sim-
ilar outcome, i.e., a significant improvement in total
VAS, SNOT-20, and endoscopic examination scores,
and in the mucociliary clearance rate. When both
groups were compared in terms of the percentage
change in subjective and objective outcomes from the
baseline, we did not find a significant difference be-
tween the two treatment modalities. There are few
direct comparisons of medical and surgical treatment
of CRSwNP in the literature. The 2012 European Posi-
tion Paper on Rhinosinusitis and Nasal Polyp indicated
that the efficacy of endoscopic sinus surgery is equiv-
alent to that of medical therapy in CRSwNP.9
However, a recent article2 by the Cochrane collabo-
ration assessed the effectiveness of endonasal and/or
endoscopic surgery versus medical treatment in sub-
jects with CRSwNP. A meta-analysis was not possible
due to the heterogeneity of the studies and incomplete
outcome reporting by the studies.2 A recent study
showed that extensive endoscopic sinus surgery (i.e.,
including middle turbinate and superior turbinate
resection with total ethmoidectomy) for patients
with CRSwNP and with asthma may better improve
the subjective olfaction and endoscopic appearance
compared with conventional endoscopic sinus
surgery11Apparently, at this time, the evidence is not
enough to show that one treatment is better than an-
other in terms of patient-reported symptom scores and
quality of life measurements.
As a new outcome parameter, we evaluated the NCI
of our study population before and after both treat-
ment modalities. It is well known that nasal congestion
is a major concern in subjects with CRSwNP. The NCI
has been indicated to have the potential to become an
important measurement for the evaluation of patients
with nasal symptoms.7 The NCI indirectly assesses the
amount of reversible mucosal congestion in the ante-
rior and middle parts of the nasal cavities, which en-
ables a quantification of nasal congestion and its effect
on nasal flow. It has been indicated that NCIs are
significantly higher in subjects with severe symptoms
e198
of nasal obstruction compared with subjects with lesser
symptoms. NCI-VOL3, in particular, has been shown
to reflect changes in nasal cavity volume after decon-
gestion, including both flow limiting and nonflow lim-
iting areas of the nasal cavities.7
Therefore, in our study, we assumed that an im-
provement in NCI, especially in NCI-VOL3, would be
observed in both groups because it is well known that
both medical and surgical treatment of CRSwNP re-
sults in a subjective improvement of nasal airflow.
Although there was a trend toward a decrease in both
study groups, no statistically significant change was
observed in NCI in both groups after treatment. Simi-
larly, the percentage change in NCI from baseline in
both groups was not significantly different. We suggest
that NCI, in subjects with CRSwNP, cannot be used as
an outcome measurement for assessing the success of
treatment. There may be several reasons for this. In
subjects with nasal polyposis, it is likely that the appli-
cation of nasal decongestants does not result in reduc-
tion in the volume of the nasal polyps or that the
presence of polyps in the nasal cavity may reduce the
decongestive ability of the nasal mucosa. The degree of
mucosal decongestion may be under- or overvalued
due to the presence of chronic inflammation, mucosal
fibrosis, and hyperplasia.7 The presence of an immu-
noglobulin E mediated type allergy was not evaluated
in our study population, and allergic rhinitis, in addi-
tion to nasal polyposis, could be a confounder for the
lack of a significant change in NCI after medical or
surgical treatment.
Rimmer et al.,2 in their Cochrane database review for
the management of patients with CRSwNP, implied
that they had low confidence in the estimates of the
reviewed studies and that further research is necessary
to change these estimates. To do so, we tried to run a
similar study to the study by Ragab et al.8 in terms of
methodology and the medical treatment regimen;
however, one limitation of our study was that the
number of participants involved was smaller and the
statistical power was inevitably low. One advantage of
our study was that our study group was homogenous,
i.e., we included only patients with CRSwNP. In addi-
tion, other than these investigators outcome measure-
ments, we used the NCI. Our results were similar for
the outcome measurements in common.
Ragab et al.8 reported no significant differences be-
tween the 6- and 12-month measurements for the sub-
jective and objective outcomes. Therefore, we believed
that our 6-month measurements could be interpreted
as long-term outcomes of treatment. Similar to their
study, we did not find any additional benefit of endo-
scopic sinus surgery instead of medical therapy on our
study population. The only significant positive effect of
surgery was observed on endoscopic nasal examina-
tion on postoperative month 3. However, no significant
Winter 2016, Vol. 7, No. 4
difference was available for postoperative month 6. As
pointed out by Rimmer et al.,2 it has not been possible
to blind either the participants or the investigators to
the medical versus surgical interventions. Because ev-
idence of surgery may be apparent on endoscopic ex-
amination, the significantly positive effect of surgery
on postoperative month 3 has a serious risk of bias.
CONCLUSION
In our study, we tried to determine which inter-
vention would lead to improvements in patient-re-
lated symptom scores and some objective measure-
ments, including the NCI, to increase the quality of
evidence to allow a robust conclusion regarding the
method of therapy to be chosen for CRSwNP. Ac-
cording to our results, the surgical and medical treat-
ments for this condition seem to be similar in out-
come, and the risks of each must be considered as the
treatment is planned. The NCI has been indicated to
have the potential to become an important measure-
ment for the evaluation of patients with nasal symp-
toms.7 However, we did not find a significant change
in NCI in both groups after treatment. Similarly, the
percentage change in NCI from baseline in both
groups were not significantly different. NCI does not
correlate with standard subjective measurements in
outcomes for this patient group. We indicated that
NCI in subjects with CRSwNP could not be used as
an outcome measurement for assessing the success
of treatment.
Allergy & Rhinology
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